Using clear aligners to expand the upper dental arch in children with cleft lip and palate
Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Pilot Study
This study is testing if clear aligners can help expand the upper jaw in children aged 6-8 with cleft lip and palate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Select) |
| Trial ID | NCT06994754 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of clear aligners in expanding the upper dental arch of children aged 6-8 years with cleft lip and palate. Participants will wear a series of aligners, each for 10 days, and attend monthly check-ups to monitor progress. The study aims to determine if these aligners can achieve significant changes in the dental and skeletal structure of the maxilla. After completing the aligner treatment, 3D x-rays and intraoral scans will be conducted to assess the outcomes of the intervention.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-8 years with bilateral cleft lip and palate who have not undergone previous orthodontic treatment.
Not a fit: Patients with syndromic cleft lip and palate or those taking medications that influence growth may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve dental arch morphology and facilitate better surgical outcomes for children with cleft lip and palate.
How similar studies have performed: While the use of clear aligners for orthodontic treatment is well-established, this specific application for maxillary expansion in cleft lip and palate patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mixed dentition. * Both males and females. * Bilateral cleft lip and palate. * Lip repair performed between 3 and 6 months of age and palate repair performed between 12and 24 months of age. * Presence of maxillary constriction that needs maxillary expansion. * Good periodontal health. * No previous orthodontic treatment. Exclusion Criteria: * Syndromic cleft lip and palate patients. * Taking medications that influence growth.
Where this trial is running
Cairo, Select
- Faculty of Dentistry - Cairo University — Cairo, Select, Egypt (Recruiting)
Study contacts
- Study coordinator: mahmoud Abo-Salem, M.SC
- Email: mahmoud.abdelsalam@dentistry.cu.edu.eg
- Phone: +201112052622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.